The study is to verify that Dermalax (Deep) is not inferior to the reference device, Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subject diary and follow up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
Chung-ang University Hospital
Seoul, South Korea
Eulji General Hospital
Seoul, South Korea
Wrinkle Severity Rating Scale(WSRS) evaluation
Wrinkle Severity Rating Scale(WSRS) evaluation at week 24
Time frame: at week 24
The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group
Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 36, week 48 by independent evaluator
Time frame: at week 8~ 48
The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group
Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 24, week 36, week 48 by investigator
Time frame: at week 8~ 48
The mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group
Global Aesthetic Improvement Scale(GAIS) evaluation at week8, week 16, week 36, week 48 by investigator
Time frame: at week 8~48
Mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group
Global Aesthetic Improvement Scale(GAIS) scores evaluation at week 8, 16, 24, 36, 48 by subjects
Time frame: at week 8~48
The proportion of subjects whose WSRS scores decreased at least 1 level
the proportion of subjects whose Wrinkle severity system scale(WSRS) scores decreased at least 1 level at week 24, 36, 48 by independent evaluator.
Time frame: at week 0~48
The proportion of subjects whose WSRS scores decreased at least 1 level
the proportion of subjects whose Wrinkle severity system scale(WSRS) scores decreased at least 1 level at week 24, 36, 48 by investigator
Time frame: at week 0~48
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